BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 175827 · Received July 1, 1998

    Report

    Report Number
    1628664-1998-00067
    Event Type
    Other
    Date Received
    July 1, 1998
    Date of Event
    May 31, 1998
    Report Date
    June 30, 1998
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON 05/31/1998 THE ACCOUNT REPORTED AN ERRATIC VALPROIC ACID RESULT OF 4.8 L/MG. THE RESULT WAS QUESTIONED AND THE SAMPLE RETESTED, GIVING 86 MG/L. THE PT HAD BEEN DOSED BASED UPON THE INITIAL RESULT. TREATMENT WAS DELAYED AND THEN READJUSTED AFTER THE VALPROIC ACID RESULT WAS QUESTIONED. NO FURTHER INFO PROVIDED FROM THE ACCOUNT. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR AXSYM VALPROIC ACID REAGENT, LIST NUMBER 7A71-20.